Viewing data from:

JOENJA

NDA

LENIOLISIB PHOSPHATE | N217759 | PHARMING TECHNOLOGIES BV

1 strength1 unique patent2 unique exclusivities

Patent Timeline

1 unique patent, 2 exclusivities by expiration date

Active (1)TodayExclusivity

2027

2028

2029

2030

2031

2032

Today

8653092

Feb. 19, 2032

NCE

Mar. 24, 2028

ODE-430

Mar. 24, 2030

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Joenja (2023)

Total Spending

$2.3M

Total Claims

Beneficiaries

—

Avg Cost/Unit

$752.01

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
May 29, 2025	SUPPL -5	View Letter (PDF)
Mar 27, 2023	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 70MG BASE

RLD

1 patent2 exclusivities▴

TABLET;ORAL | Approved: Mar 24, 2023

Patents (1)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8653092	Feb 19, 2032	—	Yes	Yes	—	—

Exclusivities (2)

Code	Date	Status
NCE	Mar 24, 2028	Active
ODE-430	Mar 24, 2030	Active